Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Oct 10, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new type of knee-ankle-foot brace designed to help improve the way children with cerebral palsy walk, especially those who have a crouched gait. Crouch gait is a common problem for kids with this condition, and the goal of the study is to find out how well different adjustments to the brace can help improve walking in children aged 5 to 17 who have cerebral palsy, as well as healthy volunteers in the same age range.

Participants will go through several visits where they will have their movements analyzed and custom braces made just for them. Children with cerebral palsy will have a total of six visits, while healthy volunteers will only need one. Throughout these visits, they will wear the braces, practice walking, and undergo some tests to see how their muscles and brain respond. To be eligible, children must be able to walk at least 10 feet, and they shouldn’t have any other serious health issues that might affect their walking. This trial could provide valuable information that helps improve mobility for kids with movement disorders.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Age 5 years and above
• • Either a healthy volunteer, have crouch gait with a diagnosis of spastic diplegic cerebral palsy, or have lower extremity weakness resulting in gait pathology from a diagnosis of muscular dystrophy, spina bifida, or incomplete spinal cord injury.
• • Able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
• • Able to provide verbal/written assent.
• • Less than 5 degrees of knee flexion contracture with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
• • Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
• • A measured foot-thigh angle of -10 to 25 degrees in prone position.
• • Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.)
• • Able to walk at least 10 feet without stopping with or without a walking aid
• • Agreement to not drink caffeine for 24 hours before each EEG assessment (CP only) visit because it can modify brain activity
• EXCLUSION CRITERIA:
• • Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time.
• • Participation in this protocol within the previous 1 year.
• ADDITIONAL EXCLUSION CRITERIA FOR INDIVIDUALS WITH CEREBRAL PALSY:
• • A history of a seizure in the past year.
• • Pregnancy